Drug Registration Approval Granted for Sihuan Pharmaceutical's Pediatric Compound Amino Acid Injection (18AA-II)

Create synergy with other injection products of the Group that have been granted approval and facilitate the Group's development in the field of infusion

HONG KONG, March 23, 2020 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd. (HKEX: 0460, "Sihuan Pharmaceutical" or the "Company", together with its subsidiaries, the "Group") is pleased to announce that drug registration approval has been granted by the National Medical Products Administration of the People's Republic of China (the ''PRC'') for the Group's pediatric compound amino acid injection (18AA-II) (the ''Product'').

The dosage form of the Product approved is injection, with specifications of 100ml: 6.0g and 250ml: 15.0g. It is a compound preparation consisting of amino acids.The Product is composed of 18 common protein amino acids and taurine.

The formula of the Product is mainly designed to simulate similar kind of amino acids in human milk. In addition to maintaining protein balance in children, it can also meet the needs of children's growth and organ development. The Product is formulated with a high concentration of branched chain amino acids and contains arginine, histidine, cysteine, tyrosine and a non-proteinogenic amino acid, taurine. The Product can provide nitrogen source for children's bodies, correct negative nitrogen balance in the body, and provide important nutritional support and treatment for infants and young children suffering from diseases.

The Product is an intravenous parenteral nutrition infusion, which can beadministered to: (1) premature infants, low-birth-weight infants, and newborns who are unable to orally consume protein or whose intakes are inadequate due to various causes; (2) children with various types of wound, such as burns and trauma, and high metabolic status after surgery; and (3) children with acute and chronic malnutrition who are unable to be fed orally or underfed and suffering from necrotizing enterocolitis and acute necrotizing pancreatitis, and showing chemotherapeutic drug response, etc.

Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical said, "The Group is the second company in the PRC that has been granted registration approval for this Product. We believe the Product will create synergy with other injection products of the Group that have been granted approval and will facilitate the Group's development in the field of infusion."

About Sihuan Pharmaceutical Holdings Group Ltd.

Founded in 2001, Sihuan Pharmaceutical is a pharmaceutical group with 21 subsidiaries and integrated R&D, production and marketing and sales capabilities. Because of the continuing efforts over the past decade, Sihuan Pharmaceutical has formed a R&D platform with over 1,000 researchers conducting more than 110 pharmaceutical research projects currently. More than 300 patents on innovative drugs were granted in China and over 80 are PCT patents, covering pipeline projects including important areas of diabetes, oncology, anti-infectives and non-alcoholic steatohepatitis etc.

Source: Sihuan Pharmaceutical Holdings Group Ltd.
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